U.S. patent number 4,573,470 [Application Number 06/615,141] was granted by the patent office on 1986-03-04 for low-profile steerable intraoperative balloon dilitation catheter.
This patent grant is currently assigned to Advanced Cardiovascular Systems, Inc.. Invention is credited to Jeffrey S. Frisbie, Wilfred J. Samson.
United States Patent |
4,573,470 |
Samson , et al. |
March 4, 1986 |
Low-profile steerable intraoperative balloon dilitation
catheter
Abstract
Low-profile steerable intraoperative balloon dilatation catheter
with a flexible core wire having proximal and distal extremities. A
flexible tube extends over the core wire and has proximal and
distal extremities with the distal extremity being bonded to the
distal extremity of the core wire to form a liquid-tight seal. A
balloon is carried by the distal extremity of the flexible tube.
The flexible tube provides a lumen extending from its proximal end
into the balloon. An adapter is secured to the proximal ends of the
core wire and the flexible tube. The adapter has at least first and
second arms with the core wire extending through the first arm and
the lumen being in communication with the second arm. A rotation
limiter is carried by the first arm and is secured to the core wire
and permits rotation of the core wire while limiting its movement
longitudinally of the axis of the core wire. The catheter has a
length so that there is approximately a one-to-one correspondence
in rotation of the tip of the core wire with the rotation of the
core wire at the proximal extremity.
Inventors: |
Samson; Wilfred J. (Saratoga,
CA), Frisbie; Jeffrey S. (San Jose, CA) |
Assignee: |
Advanced Cardiovascular Systems,
Inc. (Mountain View, CA)
|
Family
ID: |
24464166 |
Appl.
No.: |
06/615,141 |
Filed: |
May 30, 1984 |
Current U.S.
Class: |
606/194; 600/434;
600/585; 604/913; 604/96.01 |
Current CPC
Class: |
A61M
25/104 (20130101); A61M 25/0133 (20130101) |
Current International
Class: |
A61M
25/01 (20060101); A61M 29/02 (20060101); A61M
029/02 () |
Field of
Search: |
;128/344,343,772,657
;604/95,96,97,98,99,100,101,102,164,165,171 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Mancene; Gene
Assistant Examiner: Stone; Cary E.
Attorney, Agent or Firm: Flehr, Hohbach, Test, Albritton and
Herbert
Claims
What is claimed is:
1. In a low-profile steerable intraoperative balloon dilatation
catheter, a flexible core wire having proximal and distal
extremities, a flexible tubular member extending over the core wire
and having proximal and distal extremities with the distal
extremity being bonded to the distal extremity of the core wire to
form a liquid-tight seal, a balloon carried by the distal extremity
of the flexible tubular member, the flexible tubular member
providing a lumen extending from the proximal end of the flexible
tubular member and extending into the balloon, and an adapter
secured to the proximal ends of the core wire and the flexible
tubular member, the adapter having at least first and second arms
with the core wire extending through the first arm and the lumen
being in communication with the second arm, means carried by the
first arm and secured to the core wire for permitting rotation of
the core wire while limiting movement longitudinally of the axis of
the core wire, the catheter having a length so that there is
approximately a one-to-one correspondence in rotation of the tip of
the core wire with the rotation of the core wire at the proximal
extremity.
2. A catheter as in claim 1 wherein said means carried by the first
arm and for rotating the core wire includes a knob rotatably
mounted upon the arm and wherein said means for limiting movement
longitudinally of the axis of the core wire includes a member
secured to the knob together with an additional member carried by
the first arm and secured to the first arm and being engagable by
said member to prevent axial movement of said knob with respect to
said first member.
3. A catheter as in claim 1 wherein said catheter has a length of
approximately 40 centimeters.
4. A catheter as in claim 1 together with a removable protective
sheath disposed over the distal extremity and serving to protect
said balloon.
Description
This invention relates to balloon dilatation catheters and more
particularly to a low-profile steerable intraoperative balloon
dilatation catheter.
During arterial bypass surgery, it has been found that vascular
stenosis often may be better treated by utilization of a dilatation
catheter rather than by a grafting operation. Although balloon-type
dilatation catheters have heretofore been provided, none have been
particularly adapted for adjunctive dilatation of small diameter
vascular stenosis during arterial bypass surgery. There is
therefore a need for a new and improved balloon dilatation catheter
which particularly lends itself to surgical cases in which surgical
bypass of a vascular stenosis is not possible due to the size
and/or location of the lesion.
In general, it is an object of the present invention to provide a
low-profile steerable intraoperative balloon dilatation catheter
which can be utilized in conjunction with arterial bypass surgery
to dilate a vascular stenosis.
Another object of the invention is to provide a catheter of the
above character which can be readily used by the surgeon.
Another object of the invention is to provide a catheter of the
above character which can be constructed with ease.
Additional objects and features of the invention will appear from
the following description in which the preferred embodiment is set
forth in detail in conjunction with the accompanying drawing.
FIG. 1 is a side elevational view of a low-profile steerable
intraoperative balloon dilatation catheter incorporating the
present invention.
FIG. 2 is a partial isometric exploded view of the adapter used on
the dilatation catheter shown in FIG. 1.
FIG. 3 is an enlarged side elevational view of the distal extremity
of the dilatation catheter shown in FIG. 1 covered with a
protective sheath.
The low-profile steerable intraoperative balloon dilatation
catheter is comprised of a flexible core wire having proximal and
distal extremities. A flexible tubular member extends over the core
wire and has proximal and distal extremities with the distal
extremity being bonded to the distal extremity of the core wire to
form a liquid-tight seal. A balloon is carried by the distal
extremity of the flexible tubular member. The flexible tubular
member provides an annular passage or lumen extending from its
proximal end into the balloon. An adapter is secured to the
proximal ends of the flexible core wire and the flexible tubular
member. The adapter has a central arm and two side arms. The two
side arms are in communication with the lumen extending into the
balloon. The core wire extends through the central arm so it can be
used to facilitate insertion of the dilatation catheter into a
vascular passage.
More, in particular, as shown in the drawing, the low-profile
steerable intraoperative balloon dilatation catheter 11 has many
characteristics which are similar to the low-profile steerable
dilatation catheter disclosed in co-pending application Ser. No.
615,118, filed May 30, 1984. It consists of a core wire 12 formed
of a suitable material such as stainless steel. The core wire can
be dimensioned in the manner described in co-pending application
Ser. No. 615,118 filed May 30, 1984. However, it has a length which
is substantially less than the length disclosed in said co-pending
application, as for example, 40 centimeters rather than 150
centimeters. In addition, if desired, it can have a lesser
cross-sectional area because of the shorter length and the lesser
requirement for torsional rigidity.
A flexible tubular member 13 extends over the core wire 12. The
proximal extremities of the core wire 12 and the tubular member 13
are coupled to a triple arm adapter 14. The distal extremity of the
tubular member 13 carries a balloon 16. If desired, the balloon 16
can be formed integral with the tubular member 13 in a manner well
known to those skilled in the art. The extreme distal extremities
of the tubular member 13 and the core wire 12 are bonded to each
other to form a liquid-tight seal. The balloon and the liquid-tight
seal can be formed in a manner described in co-pending application
Ser. No. 522,835 filed on Aug. 12, 1983. A flexible tip 17 can be
provided on the distal extremity of the core wire 12 also in a
manner described in co-pending application Ser. No. 522,835 filed
on Aug. 12, 1983.
The tubular member 13 in conjunction with the core wire 12 provides
an annular flow passage or lumen 21 which extends from the balloon
into the triple arm adapter 14 and is in communication with the two
side arms 22 and 23 of the adapter 14. A bleed wire or vent tube 24
extends through the side arm 23 and extends into the distal
extremity of the balloon 16 so that when a radio contrast liquid is
introduced through the side arm 22, air in the balloon can pass out
through the vent tube 24. The side arm 23 is provided with a
knurled knob 26 which can be adjusted to open and close an O-ring
(not shown) with respect to the vent tube 24 and to form a
liquid-tight seal with respect to the vent tube 24.
The core wire 12 extends through the central arm 28 of the triple
arm adapter 14. The central arm is provided with a thumb screw 29
having a knurled knob 36. The thumb screw 29 is adapted to engage
an O-ring 32 to form a liquid-tight seal with respect to the core
wire 12.
Means is provided for imparting rotational movement to the core
wire 12 and consists of a knob 31 which has the core wire 12 bonded
therein so that as the knob 36 is rotated, the core wire 12 will be
rotated. The knob 36 is provided with a smooth-surfaced extension
37 which is rotatably mounted in the thumb screw 29. Pop-out stop
and rotation limiting means 33 is provided for limiting movement
axially or longitudinally of the axis of the knob 36 while still
permitting rotational movement of the knob 36. This means consists
of a stop and limiting member 38. The member 38 can be of any
desired shape. The member 38 is provided with a cutout 39 to form
spaced-apart parallel lips 41 and 42. The member 38 is mounted on
one of the knobs 31 and 36 and as shown is mounted on the knob 36
with the cutout 39 facing the knob 36 by a screw 43 threaded into a
hole 44 in the knob 36. The lip 41 overlies the knob 36 and the lip
42 underlies the knob 31. The engagement of the member 38 with the
knobs 31 and 36 prevents movement of the knob 36 longitudinally of
its axis of rotation and away from the knob 31 while permitting
rotational movement of the knob 36.
Since the catheter is utilized for intraoperative procedures, the
catheter is substantially shorter than dilatation catheters and can
have a length of approximately 40 centimeters. The core wire 12 and
the tubular member 13 are sized accordingly. The core wire can have
a diameter of 0.010 inches.
A protective sheath 46 with a funnel-shaped entrance 46a is
provided on the distal extremity of the catheter and is removable.
It serves to protect the balloon 16 and the tip 17 prior to use of
the catheter. The funnel shaped entrance 46a facilities placement
of the sheath 46 on the catheter.
Operation and use of the low-profile steerable intraoperative
balloon dilatation catheter may now be briefly described as
follows.
Let is be assumed that a bypass operation is being performed and
that it is found that a surgical bypass of a vascular stenosis is
not possible or desirable due to the size and/or location of the
lesion. Prior to the bypass surgery, all equipment to be used in
the procedure should be prepared. The balloon 16 of the catheter
should be tested to a maximum pressure as, for example, 90 psi
prior to commencement of the procedure. Typically the balloon can
be inflated with a sterile saline solution. However, if
intraoperative X-ray or fluoroscopy is to be utilized, the balloon
should be filled utilizing a 60% contrast medium.
The protective sheath 46 is slid off of the balloon 16. A 10 cc
syringe can be connected to the balloon inflation arm 22 and the
balloon inflated with air. The knurled screw 26 mounted on the side
arm 23 is loosened and a vent tube or wire 24 is inserted into the
same and carefully advanced into the lumen 21 until it reaches the
balloon 16 and is near the distal extremity of the balloon 16.
Thereafter the thumb screw 26 is adjusted until the O-ring (not
shown) is almost but not quite closed around the vent tube.
A balloon inflating device such as that described in U.S. Pat. No.
4,439,185 and called an Indeflator is filled with approximately 6
to 10 cc of a balloon inflation medium utilizing a conventional
contrast medium. Holding the adapter 14 so that the inflation arm
23 is at the bottom, the contrast liquid is introduced into the arm
23 by the Indeflator. The thumb screw 26 is closed to ensure that
the inflation medium does not leak around the vent tube 24. Then
while keeping the balloon 16 at a level above the adapter, the
balloon 16 is slowly filled with the inflation medium by
maintaining a constant pressure. As the balloon is filled the air
is removed from the balloon by the vent tube 24. After the balloon
and the lumen 21 leading to the balloon have been completely filled
with the contrast medium, the vent tube 24 can be withdrawn from
the balloon. To facilitate this removal, the thumb screw 26 may
have to be loosened. Typically the vent tube 24 can be removed and
discarded. However, if it is desired to utilize the vent tube as a
stiffner for the shaft of the catheter, the vent tube can be
withdrawn until its distal extremity is approximately 5 centimeters
from the balloon 16. The proximal extremity of the vent tube can
then be looped and inserted through the O-ring and closed off by
closing the thumb screw 26.
Prior to insertion of the dilatation catheter into and withdrawing
it from the artery and the stenosis in the artery, a negative
pressure must be maintained on the balloon 16 to keep it totally
deflated to its minimum size.
The extent and degree of stenosis to be dilated are shown by the
preoperative angiogram. Operative calibration before dilatation,
however, will confirm the angiographic finding and will provide an
accurate measurement of the distance to the stenosis from the
arteriotomy.
To facilitate the correct positioning of the balloon 16 in the
stenosis, an adjustable marker (not shown) can be provided on the
dilatation catheter and can be set to the distance measured by the
calibrater. This indicates the desired catheter insertion distance
from the arteriotomy. As soon as the dilatation catheter has been
inserted into the desired position, the balloon can be inflated to
its maximum size by using the contrast medium to dilate the
stenosis to the desired extent. After this has been accomplished,
once or twice, the balloon 16 is again deflated and the catheter 11
can be removed and discarded.
In inserting the catheter 11 into the stenosis, the flexible tip 17
which is provided facilitates introduction of the catheter into the
stenosis. This is also facilitated by the fact that the distal
extremity of the catheter can be rotated to cause rotational
movement of the tip 17 by rotating the knob 36.
It is apparent from the foregoing that there has been provided a
low-profile steerable intraoperative dilatation catheter which is
particularly useful for performing dilations of arteriostenosis
which are not amenable to a suitable surgical bypass because of
size and location of the lesions. The catheter is constructed in
such a manner so that it can be readily utilized by the surgeon
during bypass operations. It is of relatively short configuration
so that it can be readily manipulated by the physician. Rotation
can be readily imparted to the tip by rotation of a knob. Because
of the relatively short length of the catheter, there is sufficient
torsional rigidity in the core wire so that there is almost a
one-to-one correspondence between rotation of the knob and rotation
of the tip of the catheter. The catheter is constructed in such a
manner so that the tip cannot pop out or be pulled out
accidentally.
* * * * *